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| ID | Type | Description | Link |
|---|---|---|---|
| vot 1471 | Other Grant/Funding Number | The European Society for Paediatric Gastroenterology Hepatology and Nutrition |
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| Name | Class |
|---|---|
| European Society of Pediatric Gastroenterology, Hepatology and Nutrition | OTHER |
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This study is designed to compare the effects of four relaxation interventions on both physiological and psychological outcomes in lactating mothers of preterm infants. The interventions being tested include:
The primary objectives of the study are to evaluate and compare how these different relaxation techniques influence the physiological and psychological well-being of mothers and identify which intervention is most effective for lactating mothers who deliver prematurely.
The main research questions are:
Study Design:
Each participant will be exposed to five different sessions (one for each intervention), with a gap of 1-2 days between sessions. The interventions will be administered as follows:
Expected Outcomes:
This study will assess the following physiological and psychological outcomes:
Physiological changes:
Psychological changes:
•. Perceived Relaxation
The trial aims to recruit 30 mothers of premature infants who are born between 28 and 35 weeks, which falls under the categories of early and mid-preterm. Participants will be recruited among mothers aged between 18 and 49 who are non-smokers, with no medical condition that could affect breastfeeding, and also those who are not taking any psychiatric medication, and those who are not diagnosed with mental illness. This trial also aims to recruit Muslim mothers, since one of the interventions is Religious Recitation which focuses on Qur'anic verses.
The participants will be identified through recent hospital data on premature infants born between 28 to 35 weeks gestation and through a face-to-face approach. The study information sheet will be given to interested mothers. Eligible mothers will be given consent forms after assessing the inclusion and exclusion criteria for mothers and infants. The participants will be enrolled in the study and randomized using a computerized random number generator, where the participants cannot choose which intervention to test first. One person who had no contact with the participants will do randomization five times for each participant since four interventions and controls were involved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided Imagery Meditation | Experimental | Participants will need to listen to the guided imagery meditation tape that was developed by Sheri Menelli in 2004 for breastfeeding mothers as it has been successfully used before. |
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| Religious Recitation | Experimental | -Participants will need to listen to Surah Ar-Rahman, which will be used in this study since it has been done previously among pregnant women in the labour process. |
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| Infant Video with Music | Experimental | The video will be played for 10 minutes duration and mothers will need to hold the phone to look at the slide show of their infant's image and video that will be recorded by the researcher prior session |
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| Distraction with News and Media | Experimental | The researcher will instruct mothers to use their phones as they did at home for 10 minutes to measure how this distraction affects the mother's physiology and psychology. |
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| Control | Experimental | No intervention but all participants will ask to sit for 10minutes . Minimum distraction will be applied. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Imagery Meditation | Behavioral | Audio meditation by Sheri Menelli, for 10-14minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate (BPM) | Pre- and post-measurement of heart rate in beats per minute (BPM). | From enrollment to the end of the 5-session intervention (within 2 weeks). |
| Systolic Blood Pressure (SBP) | Pre- and post-measurement of systolic blood pressure in millimeters of mercury (mmHg). | From enrollment to the end of the 5-session intervention (within 2 weeks). |
| Diastolic Blood Pressure (DBP) | Pre- and post- measurement of diastolic blood pressure in millimeters of mercury (mmHg). | From enrollment to the end of the 5-session intervention (within 2 weeks). |
| Fingertip Temperature (FT) | Pre- and post-measurement of fingertip temperature in degrees Celsius (°C). | From enrollment to the end of the 5-session intervention (within 2 weeks). |
| Breast Milk Cortisol Level | Pre- and post-measurement of cortisol levels in breast milk, typically expressed in nanograms per milliliter (ng/mL). | From enrollment to the end of the 5-session intervention (within 2 weeks). |
| Perceived Relaxation (PR) | Pre- and post-measurement of perceived relaxation levels, using a 10 cm Visual Analogue Scale (VAS). The scale ranges from 0 to 10 cm, where 0 cm (on the left) represents "completely unrelaxed" and 10 cm (on the right) represents "completely relaxed." Participants will mark a point on the scale that reflects their level of relaxation at the specified time. | From enrollment to the end of the 5-session intervention (within 2 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Fat | Pre- and post- measurement of milk fat content in grams per 100 milliliters (g/100 mL) | From enrollment to the end of the 5-session intervention (within 2 weeks). |
| Carbohydrate | Pre- and post- measurement of milk carbohydrate content in grams per 100 milliliters (g/100 mL). |
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Inclusion Criteria ( Mothers)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Nurul Husna Mohd Shukri | Contact | +603-97692963 | n_husna@upm.edu.my | |
| Nazratul Fareha Azman | Contact | +60134974704 | gs67689@student.edu.upm.my |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sultan Abdul Aziz Shah UPM, Serdang Selangor | Recruiting | Serdang | Selangor | 43400 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31889973 | Background | Yu J, Wells J, Wei Z, Fewtrell M. Effects of relaxation therapy on maternal psychological state, infant growth and gut microbiome: protocol for a randomised controlled trial investigating mother-infant signalling during lactation following late preterm and early term delivery. Int Breastfeed J. 2019 Dec 16;14:50. doi: 10.1186/s13006-019-0246-5. eCollection 2019. | |
| 30351172 |
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The study results, including aggregated data, will be shared to contribute to broader scientific understanding. However, due to privacy and confidentiality concerns, individual participant data will not be shared. Only de-identified, summary-level data (e.g., group results, statistical analyses) will be made available to the public or other researchers.
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It is a "within-subject randomized trial" is a type of experimental study where each individual is exposed to more than one treatment. In this design, each participant acts as their own control, which helps to control for individual differences and reduces variability.
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|
| Religious Recitation | Behavioral | listen to Surah Ar-Rahman for 14 minutes |
|
| Infant Video with Music | Behavioral | 10 minutes of slides show of infant's image and video |
|
| Distraction with News and Media | Behavioral | 10 minutes of phone use |
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| Control | Behavioral | All participants will ask to sit for 10minutes . Minimum distraction will be applied such as minimal or no chatting. |
|
| Frame: From enrollment to the end of the 5-session intervention (within 2 weeks) |
| Total energy | Pre- and post-measurement of total energy content in kilocalories per 100 milliliters (kcal/100 mL) | Frame: From enrollment to the end of the 5-session intervention (within 2 weeks) |
| Yu J, Wells J, Wei Z, Fewtrell M. Randomized Trial Comparing the Physiological and Psychological Effects of Different Relaxation Interventions in Chinese Women Breastfeeding Their Healthy Term Infant. Breastfeed Med. 2019 Jan/Feb;14(1):33-38. doi: 10.1089/bfm.2018.0148. Epub 2018 Oct 23. |
| 29105966 | Background | Mohd Shukri NH, Wells JCK, Fewtrell M. The effectiveness of interventions using relaxation therapy to improve breastfeeding outcomes: A systematic review. Matern Child Nutr. 2018 Apr;14(2):e12563. doi: 10.1111/mcn.12563. Epub 2017 Nov 6. |
| 31161202 | Background | Mohd Shukri NH, Wells J, Eaton S, Mukhtar F, Petelin A, Jenko-Praznikar Z, Fewtrell M. Randomized controlled trial investigating the effects of a breastfeeding relaxation intervention on maternal psychological state, breast milk outcomes, and infant behavior and growth. Am J Clin Nutr. 2019 Jul 1;110(1):121-130. doi: 10.1093/ajcn/nqz033. |
| 28900859 | Background | Rafique R, Anjum A, Raheem SS. Efficacy of Surah Al-Rehman in Managing Depression in Muslim Women. J Relig Health. 2019 Apr;58(2):516-526. doi: 10.1007/s10943-017-0492-z. |
| 34624025 | Background | Nomkin LG, Gordon I. The relationship between maternal smartphone use, physiological responses, and gaze patterns during breastfeeding and face-to-face interactions with infant. PLoS One. 2021 Oct 8;16(10):e0257956. doi: 10.1371/journal.pone.0257956. eCollection 2021. |
| 22469966 | Background | Keith DR, Weaver BS, Vogel RL. The effect of music-based listening interventions on the volume, fat content, and caloric content of breast milk-produced by mothers of premature and critically ill infants. Adv Neonatal Care. 2012 Apr;12(2):112-9. doi: 10.1097/ANC.0b013e31824d9842. |
| 26023551 | Background | Ak J, Lakshmanagowda PB, G C M P, Goturu J. Impact of music therapy on breast milk secretion in mothers of premature newborns. J Clin Diagn Res. 2015 Apr;9(4):CC04-6. doi: 10.7860/JCDR/2015/11642.5776. Epub 2015 Apr 1. |
| 32509467 | Background | Dib S, Wells JCK, Fewtrell M. A within-subject comparison of different relaxation therapies in eliciting physiological and psychological changes in young women. PeerJ. 2020 May 22;8:e9217. doi: 10.7717/peerj.9217. eCollection 2020. |
| 26495909 | Background | Holditch-Davis D, Santos H, Levy J, White-Traut R, O'Shea TM, Geraldo V, David R. Patterns of psychological distress in mothers of preterm infants. Infant Behav Dev. 2015 Nov;41:154-63. doi: 10.1016/j.infbeh.2015.10.004. Epub 2015 Oct 22. |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
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| D003470 | Culture Media |
| ID | Term |
|---|---|
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D004864 | Equipment and Supplies |
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